The FDA has recently released a public warning regarding Uloric, stating that a recent study found that patients faced an increased risk of cardiac related deaths. This study was a post market study of the Uloric medicine, which was mandated by the FDA as part of the condition for the drug’s release into the market.

The Uloric medicine was approved by the FDA in 2009, in which the agency required the Chicago based company Takeda Pharmaceuticals to perform a post market study to observe the drug’s potential side effects. Before the Uloric medicine gained FDA approval, pre clinical trials had found that the drug could increase the risk of heart attacks, strokes, and cardiac related deaths.

Uloric Post Market Study

While pre-clinical trial complications were mentioned on the Uloric warning label, the FDA ordered Takeda to perform a follow up study after the drug was released. The post market study reportedly consisted of over 6,000 patients who were prescribed allopurinol or the Uloric medicine to treat gout, and compared the risks of cardiac complications.

The results showed that Uloric patients had experienced a higher likelihood of cardiac related death, non fatal heart attack, non fatal stroke, and cardiac ischemia, which occurs when there is insufficient blood supply to the heart and requires urgent surgery.

Soon after Takeda Pharmaceuticals released findings of the clinical trial, the FDA released two warnings regarding the Uloric medicine and increased risk of cardiac related deaths.

These Drug Safety Communications were released on Nov. 15, 2017, with the first warning stating that the Uloric medicine could cause an increased risk of cardiac death. The second FDA warning stated that the agency would also be investigating all potential patient deaths that may be linked to the Uloric medication.

“Health care professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat. [P]atients should talk to your health care professionals if you have any questions or concerns. Do not stop taking your medicine without first consulting with your health care professional,” the FDA states.

Overview of Uloric Medicine Concerns

Uloric is one of the most popular treatment medications for gout, which is a condition that affects millions of patients across the United States. Gout is a form of arthritis that typically forms in the joints, due to a build up of uric acid. Uloric and other treatment drugs work by lowering uric acid levels in the blood, which is supposed to help alleviate symptoms.

The recent study, however, has spurred major concern in the patient population and medical community in the United States, as well as a class action investigation against Takeda Pharmaceuticals.

Before the FDA warnings were released in 2017, Takeda Pharmaceuticals had faced a whistleblower lawsuit in 2012 that was filed by a former company safety consultant.

The whistleblower claim alleged that Takeda Pharmaceuticals concealed important drug safety information on the Uloric medicine from the federal government. Even though there is an allegedly increased risk of cardiac death in conjunction with the Uloric medicine, it’s claimed that Takeda Pharmaceuticals failed to disclose this information to the general public.